SPL v2
SPL
SPL Set ID cbad9b68-12e8-4766-893b-a0ed6b1f0484
Route
TOPICAL
Published
Effective Date 2013-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (34.86 g)
Inactive Ingredients
Aloe Vera Leaf Glycerin Xanthan Gum Methyl Salicylate Chinese Cinnamon Oil Camphor Oil Matricaria Recutita Symphytum Uplandicum Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-01-15

Description

Drug Facts

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Drug Facts

Uses

Temporarily relieves minor pain associated with: muscle sprains, muscle strains, neck/back aches/pains, sore joints, arthritis, cramps and bruises.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask a health professional if condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, or if irritation occurs. If pregnant or breast feeding ask a health care professional before use. Store at room temperature.

Section 50567-7

When using this product: Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

Section 50570-1

Do not use with a heating pad or other ointments, creams, sprays or liniments. Do not apply to irritated skin. Wash hands thoroughly after each application.

Warnings

For external use only. Flammable. Keep away from open flame or extreme heat.

Directions

For adults and children 6 years of age and older: Shake well. Clean skin. Apply a liberal amount of gel directly on the skin over the affected area until absorbed into skin. Repeat as necessary, but not more than 4 times daily. May also be applied before or after activity. For children under 6 years of age, consult a health care professional.

Active Ingredient

Menthol 3.5%

Inactive Ingredients

Aloe Barbadensis (Aloe) Leaf Gel, SDA 38B, Glycerin, Xanthan Gum, Gaultheria Procumbens (Wintergreen) Leaf Oil, Cinnamomum Cassia (Cassia) Oil, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria), Organic Symphytum Officinalis (Comfrey)

RAW Health International, LLC

91 Ft. Couch Road-Pittsburgh, PA 15241

www.rawhealthintl.com

Ph: 1-888-RAW-HLTH

Questions Or Comments:

Email us at: [email protected]

MSRP $14.99

Principal Display Panel – 3 Oz. Bottle

RAW

RAW HEALTH INTERNATIONAL

HEAT

The All-Natural

Warming Pain Reliever

Muscle Strains,

Joint Sprains, Neck/Back Aches,

Pains and Much More…

3 fl OZ / 89 mL

www.rawhealthintl.com

Also Try RAW-ICE for cooling pain relief


Structured Label Content

Uses

Temporarily relieves minor pain associated with: muscle sprains, muscle strains, neck/back aches/pains, sore joints, arthritis, cramps and bruises.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a health professional if condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, or if irritation occurs. If pregnant or breast feeding ask a health care professional before use. Store at room temperature.

Section 50567-7 (50567-7)

When using this product: Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

Section 50570-1 (50570-1)

Do not use with a heating pad or other ointments, creams, sprays or liniments. Do not apply to irritated skin. Wash hands thoroughly after each application.

Purpose

Pain Reliever

Warnings

For external use only. Flammable. Keep away from open flame or extreme heat.

Directions

For adults and children 6 years of age and older: Shake well. Clean skin. Apply a liberal amount of gel directly on the skin over the affected area until absorbed into skin. Repeat as necessary, but not more than 4 times daily. May also be applied before or after activity. For children under 6 years of age, consult a health care professional.

Active Ingredient

Menthol 3.5%

Inactive Ingredients

Aloe Barbadensis (Aloe) Leaf Gel, SDA 38B, Glycerin, Xanthan Gum, Gaultheria Procumbens (Wintergreen) Leaf Oil, Cinnamomum Cassia (Cassia) Oil, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria), Organic Symphytum Officinalis (Comfrey)

RAW Health International, LLC

91 Ft. Couch Road-Pittsburgh, PA 15241

www.rawhealthintl.com

Ph: 1-888-RAW-HLTH

Questions Or Comments: (Questions or comments:)

Email us at: [email protected]

MSRP $14.99

Principal Display Panel – 3 Oz. Bottle (PRINCIPAL DISPLAY PANEL – 3 oz. bottle)

RAW

RAW HEALTH INTERNATIONAL

HEAT

The All-Natural

Warming Pain Reliever

Muscle Strains,

Joint Sprains, Neck/Back Aches,

Pains and Much More…

3 fl OZ / 89 mL

www.rawhealthintl.com

Also Try RAW-ICE for cooling pain relief


Advanced Ingredient Data


Raw Label Data

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